Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality

Session Chair(s)

Amanda Marie Roache, MS

Amanda Marie Roache, MS

Senior Director, Science and Regulatory Advocacy

Phrma, United States

This session will provide an overview of ICH quality topics instrumental to the harmonization of pharmaceutical development and manufacturing standards and an introduction to the new and revised topics that are currently underway.

Learning Objective : Discuss the role of ICH quality topics in harmonizing standards for more efficient pharmaceutical development and manufacturing; Explain current ICH guidelines being revised, new guidelines being developed, and their anticipated impact to pharmaceutical development and manufacture.

Speaker(s)

Ashley  Boam, MS

ICH Strategy to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches

Ashley Boam, MS

FDA, United States

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER

Andrew  Chang, PhD

Industry Perspective on ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Produce Lifecycle Management

Andrew Chang, PhD

Novo Nordisk, United States

Vice President, Quality and Regulatory Compliance

Nina S. Cauchon, PhD

Q2(R2)/Q14 Analytical Procedure Development and Validation

Nina S. Cauchon, PhD

Amgen, United States

Director Regulatory Affairs CMC

Sau L Lee, PhD

Q13 Continuous Manufacturing

Sau L Lee, PhD

FDA, United States

Deputy Super Office Director, OPQ, CDER

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.